Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head an… (NCT02474368) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study Evaluating a Stereotactic Boost/Treatment for Recurrent or Metastatic Cancer of the Head and Neck
United States21 participantsStarted 2015-11
Plain-language summary
This research study seeks to gain new knowledge about the addition of a carefully targeted "boost" dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. The name of the study intervention involved in this study is stereotactic body radiotherapy, which is a way of delivering radiation in a more precisely targeted way and with a higher dose than conventional radiotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* All cohorts:
* Participants must have a pathologic cancer diagnosis.
* No other active malignancy within the past 2 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix.
* Only patients 18 years and older are eligible. There is no upper age limit but the patients must be able to medically tolerate the regimen. Adverse event data are currently unavailable on the use of SBRT for participants \< 18 years of age, and thus children are excluded from this study.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix A).
* Ability to understand and the willingness to sign a written informed consent document
* Cohort 1 (reirradiation in patients with head and neck cancers with gross unresectable disease):
* History of radiation to the head and neck area (defined as above the clavicles) greater than 6 months previous
* Pathologically proven recurrent disease or a second primary (squamous cell carcinoma of the head and neck, nasopharyngeal cancer, salivary gland cancer, or thyroid cancer) within the head and neck region, deemed to be unresectable or resected with gross residual disease remaining (determined by either operative/pathology report or post-surgical imaging)
* Participants must have normal organ and marrow function as defined below:
* Leukocytes ≥ 3,000/mcL (microliter)
* Absolute n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given as a boost in combination with cisplatin and intensity modulated radiation therapy (IMRT)
Timeframe: 1 Year
2
Maximum tolerated dose of stereotactic body radiotherapy treatment (SBRT) when given for disease metastatic to the head and neck